Abstract
Research Type:
Level 4 – Case series
Introduction/Purpose:
Haglund’s deformity is a common cause of posterior heel pain, often necessitating surgical intervention when conservative management fails. However, current literature about clinical significance thresholds for patient-reported outcome measures (PROMs) following Haglund’s excision surgery and Achilles tendon repair for Haglund’s deformity has been poorly defined. This study aims to establish the Minimal Clinically Important Difference (MCID), Patient Acceptable Symptom State (PASS), and Substantial Clinical Benefit (SCB) for the Foot and Ankle Ability Measure (FAAM), Visual Analog Scale (VAS) for pain, and the Patient-Reported Outcomes Measurement Information System Physical and Mental Health (PROMIS-PH/MH) in patients undergoing surgical treatment for Haglund’s deformity. By quantifying these thresholds, we seek to enhance clinical decision-making and improve patient counseling regarding expected surgical outcomes.
Methods:
This sample was drawn from a prospectively collected institutional database of consecutive patients who underwent Haglund’s excision surgery by multiple surgeons from a single institution between June 2016 and February 2023. The MCID, PASS, and SCB were calculated for the FAAM Activities of Daily Living (ADL), VAS, PROMIS-10 MH, and PROMIS-10 PH utilizing either anchor- or distribution-based methods. For MCID, the two distribution-based methods used were the Standard Error of Measurement (SEM) and the 95% Minimum Detectable Change (MDC) as these have been shown to best align with the anchor-based clinical cutoffs. For PASS and SCB, anchor-based methods were used receiver operating characteristic (ROC) curve analysis to identify optimal cutoffs using the Youden J statistic.
Results:
74 patients were included in the final analysis. This cohort was aged 54.4 ± 20.1 with mean follow-up of 11.7 months. 6 (8.1%) patients experienced complications. The MCID values for SEM and MDC methods were 6.56 and 18.2 for FAAM ADL, 0.43 and 1.19 for VAS, 1.41 and 3.91 for PROMIS-10 MH, and 0.99 and 2.75 for PROMIS-10 PH, respectively. The PASS values for ROC methods were 66.07 for FAAM ADL, 1.50 for VAS, 14.50 for PROMIS-10 MH, and 15.50 for PROMIS-1 PH, respectively. Finally, the SCB values for ROC methods were 69.04 for FAAM ADL, 2.50 for VAS, 14.50 for PROMIS-10 MH, and 16.50 for PROMIS-10 PH, respectively.
Conclusion:
This study adds to the growing body of literature characterizing clinically significant differences in patient-reported outcomes in the setting of Haglund’s excision surgery for patients with posterior instability. Thresholds defined in this study may provide additional information for physicians to better interpret patient-reported outcome measures and enhance the detection of an unsuccessful outcome following surgical management for Haglund’s deformity.
Rate of Patients Meeting Clinical Significance for MCID (SEM and MDC), PASS, & SCB.
